LEGAL COUNSEL
Physician Liability for Malfunctioning Equipment Peter B. Mancino, Esq, Peter G. Siachos, Esq INTRODUCTION Picture this: you are conducting what seems to be a routine medical procedure, and the unexpected occurs: your equipment malfunctions, causing injury to the patient. Of course, your first concern is the well-being of your patient, the patient’s immediate need for medical care, and, ultimately, the patient’s recovery. However, as with any negative medical turn of events, your other concern is whether the alleged injury will result in a malpractice action. Can patients sue their physicians when medical equipment malfunctions and causes them injury? Depending on the jurisdiction, maybe. In addition to the myriad suits brought against physicians for alleged negligence, many patients have attempted to bring suit against physicians for injuries caused by malfunctioning equipment. Courts in various federal and state jurisdictions have considered application of the theories of strict liability in tort and breach of warranty against medical practitioners for patient injuries caused by medical devices or equipment used in treatment. This article explores these theories and selected representative decisions both for and against physician liability. THE THEORIES OF STRICT LIABILITY IN TORT AND BREACH OF WARRANTY It is first important to understand the two theories under which courts have considered the liability 546
of physicians for medical equipment malfunctions: strict liability and breach of warranty. What Is Strict Liability? Strict liability is a legal doctrine that makes a person responsible for injuries caused by that person’s acts and omissions, regardless of culpability. In a strict liability action, the plaintiff needs to prove only that the injury happened and that the defendant was somehow responsible for the injury. The doctrine is intended to discourage reckless behavior and needless loss by forcing defendants to take every possible precaution to ensure that their actions, including the operation of medical equipment, do not cause injury. Strict liability can create liability for the manufacturer, seller, and sometimes operators1 of products that cause injuries, without proof of negligence or other fault, for injuries to the users or consumers of the products, specifically if the products are inherently dangerous. For example, the manufacturing of dynamite, the breeding of vicious dogs, and the operation of a machine that gives off extensive amounts of radiation might all be considered “inherently dangerous activities.”
What Is a Warranty? A warranty is a statement, expressed, implied, or both, by a seller, that a product will perform as a reasonable end user2 would expect or is consistent with its published specifications. Unlike strict liability claims, which focus on the condition of a product (ie, whether it is inherently dangerous), warranty claims focus on representations by sellers to end users. Product liability claims based on breach of warranty usually focus on 1 of 3 types of warranties: (1) express warranties, (2) implied warranties of merchantability, and (3) implied warranties of fitness for a particular purpose. Express warranty claims focus on express statements by sellers concerning products, their capability, and their safety. For example, the statement “this machine will safely determine whether you have cancer without any injury to you” is an express warranty. Implied warranties cover those expectations common to all products (eg, that a product is not unreasonably dangerous when used for its proper purpose), unless specifically disclaimed by their sellers. For example, an implied warranty exists when a patient reasonably expects a CT scanner to operate properly and not cause injury. The determinative issue in assessing the liability of physicians
1
For simplicity’s sake, manufacturers, sellers, and operators are each referred to as “sellers” throughout this article. In claims against physicians for malfunctioning equipment, the physicians are sometimes considered the sellers or the operators.
2
End user is a term of art in theories of strict liability and breach of warranty that in this article refers to either a patient who is injured by medical equipment or a physician who uses the equipment, depending on the jurisdiction.
© 2008 American College of Radiology 0091-2182/08/$34.00 ● DOI 10.1016/j.jacr.2008.01.020
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for malfunctioning equipment is whether they made representations regarding the quality of the equipment, and whether a sale existed, independent of the medical services provided, on which strict liability or warranty actions could be predicated. RATIONALE FOR NONLIABILITY Most attempts to apply principles of strict liability and breach of warranty have been unsuccessful. Although routine medical malpractice lawsuits for alleged negligence of health care providers have, over the years, been brought with success, courts have generally refused to apply the rules of strict liability and breach of warranty in actions against health care providers for numerous reasons. The most frequently mentioned rationale is that physicians are engaged in the rendering of professional services, not in the business of selling, distributing, or supplying products. Because the provision of a medical instrument is incidental to the essential business of medical treatment, courts are reluctant to impose additional responsibility on physicians for the actual performance of the medical equipment. In addition, because the policy behind strict liability is for a seller to ensure that a product is safe, courts have found that the application of strict liability to health care providers would not serve these policy interests, because physicians generally do not manufacture or sell the equipment they use. For these reasons, there have been very few successful strict product liability cases against hospitals or physicians. Additionally, most courts have also found for hospitals or physicians in breach-of-warranty cases, although a few courts have found for patients.
Representative Decisions Several courts have refused to find hospitals or physicians strictly liable for defective medical devices. Courts reason that health care providers are the end users of the devices and are not “transferring” them to patients. In cases involving devices that are intimately connected to the service provided by the physicians, the devices lose their separate character as goods. In such a case, no “sale” occurs with respect to the health care provider and the patient, and therefore, claims of strict liability and breach of warranty are not applicable [1,2]. Even in a case in which a hospital charges a patient for a medical device, a sale does not occur if the use of the device is incidental to the services provided to the patient [3]. In some cases, it may not be readily apparent whether injuries were caused by professional negligence or by defective products or devices. In one New Jersey case [4], the parties ultimately agreed that an injury was the result of a defective needle and not caused by the defendant dentist’s improperly administrating an injection. The court refused to find the dentist liable because (1) the dentist was in no better position than the patient to discover the defect, (2) the dentist did not put the needle into the stream of commerce (ie, sell it to the public), and (3) the dentist had control of his professional skills but, as to the instruments he used, had no control with respect to a latent defect in a product. Additionally, the court rejected the patient’s contention that the dentist was in a position to spread the risk by obtaining liability insurance, because the risk would be spread to patients by way of increased fees, and the spreading of losses to the patients would not support the policy consideration that the loss
should be imposed upon those best able to withstand it, such as the manufacturers or sellers of products. The court noted that although the dentist could have sued the manufacturer of the needle, effectively bringing it into the case and placing the loss where it belonged, the dentist did not know from whom the needle was purchased. The court concluded that to impose strict liability on a health care practitioner in such a situation would add an irrational consequence to the field of tort law. In a Florida case [2], a patient brought suit after he sustained burns during a medical procedure. The jury returned a verdict for the patient on a strict liability claim, after it was determined that a nurse did not properly prepare the patient for the procedure. The appellate court reversed the judgment, finding that those who profit from the sale or distribution of products should bear the financial burden of product defects. The court noted that strict liability and breach of warranty apply to a defendant who is in business as a manufacturer or seller, not to a physician who uses equipment to treat patients. Finally, several courts have found that the administration of radiation, whether for diagnostic or treatment purposes, does not constitute a sale, is not necessarily inherently dangerous, and therefore does not subject a physician to strict liability [5-7]. RATIONALE FOR LIABILITY Although courts are reluctant to expand the liability of health care providers, plaintiffs can still proceed against hospitals or physicians on claims of strict liability or breach of warranty by asserting two main elements. First, the plaintiff must argue that the injury-producing treat-
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ment was somehow a sale of a product, in addition to the provision of a professional service. Second, the plaintiff must argue that the policy behind strict liability and breach of warranty—to ensure that sellers make their products safe— would also tend to ensure that physicians make their medical equipment safe. Of course, the mere filing of a claim based on these elements does not mean that a plaintiff will recover. In fact, any such claim would likely be filed along with a malpractice negligence claim in an effort to beef up a plaintiff’s case. However, there are very few decisions in which patients have successfully sued physicians on the basis of theories of strict liability and breach of warranty. Representative Decisions Courts have found that physicians breached warranties, either expressed or implied, to patients with respect to devices implanted into the patients. In a 1997 decision, a Missouri court [8] found that a physician was liable for strict liability when mandibular implantation surgery went poorly and the patient suffered severe injury, allegedly because of a defect in the implants. The court found that the patient had adequately asserted the requisite elements of the strict product liability action on the basis of a design defect, including allegations that (1) the implants were sold to her in the course of treatment, (2) the implants were in a defective condition and unreasonably dangerous when they were put to their reasonably anticipated use, (3) the implants were used in a manner reasonably anticipated to correct her joint dysfunction, and (4) as a result of the defect, the patient was injured. The court also found her complaint for a failure to warn to be sufficient. The court also found
that the purpose of strict product liability is to “socialize” losses associated with and caused by defective products, and a finding of liability would do just that. Accordingly, the strict liability claim was allowed to persist.3 In a New York lawsuit [9], a patient alleged that a broken intramedullary pin had been warranted as properly manufactured and free of defects. The patient also asserted that the physician had assured him that the pin would not break and was as strong as, if not stronger than, the original bone. The court, denying a motion to dismiss the complaint, found that the patient would face the difficulty of establishing that the furnishing of the pin constituted an isolated sale as opposed to a whole transaction for services. The court explained that a warranty theory is not applicable to a contract for services, such as the use of a physician’s skills to treat a patient. The court also found that where the equipment and services are actually directed to the restoration of a patient’s health, the transaction between a doctor and a patient is categorized as one for services. However, because the physician had “warranted” the quality of the medical device, it might still be “possible” for the patient to prove that a sale, as opposed to the provision of services, had occurred. The court was therefore reluctant to dismiss the suit. A court may find that a physician by implication warrants an instrumentality to be reasonably fit for its intended purpose simply by using such instrumentality [10,11] or that a physician expressly warrants that a product is free of defects if 3
Notably, in 2000, the Missouri court overruled this decision, finding that the state legislature intended to eliminate the liability of health care providers for strict liability through the enactment of Missouri state statute § 538.205(5).
such physician makes assertions regarding the quality of the device [9]. Similarly, if the defect could have been discovered through a reasonable inspection, a court may find that a breach of warranty occurred [10]. CONCLUSION Claims for strict liability and breach of warranty can certainly be asserted alongside claims for medical malpractice on the basis of the negligence of physicians. If hospitals or physicians make representations regarding the quality of the equipment, or if the use of the equipment is inherently dangerous, such claims could likely persist to a potential trial or, at a minimum, will cause the physicians much angst until the resolution of the matter. Even though few plaintiffs have successfully prosecuted claims of product liability or breach of warranty against hospitals or physicians, potential plaintiff patients could use such theories to bolster malpractice suits or for leverage during settlement negotiations. Hospitals and physicians should be particularly careful when promoting or advertising products or devices, because statements made in support of particular products could be viewed as express warranties. Additionally, it is possible to negotiate the insertion of indemnification clauses into agreements for the purchase, lease, or maintenance of medical equipment, wherein the manufacturer or company selling or leasing the equipment promises to indemnify a physician for any losses that may be caused by the malfunction of the machine. A simple review of such agreements by competent counsel, coupled with restraint in promotion and advertising, could help protect a physician in strict liability or warranty
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litigation for malfunctioning equipment.
REFERENCES 1. Easterly v HSP of Texas, Inc., 772 SW 2d 211 (Tex App Dallas 1989). 2. North Miami General Hospital, Inc. v Goldberg, 520 So 2d 650 (Fla Dist Ct App 3d Dist 1988).
3. Redwine v Baptist General Convention of State of Oklahoma, 681 P 2d 1121, 34 UCC Rep Serv (CBC) 883 (Okla Ct App Div 2 1982). 4. Magrine v Krasnica, 94 NJ Super 228, 227 A 2d 539 (County Ct 1967), judgment aff’d, 53 NJ 259, 250 A 2d 129 (1969).
7. Nevauex v Park Place Hospital, Inc., 656 SW 2d 923 (Tex App 1983). 8. Budding v SSM Healthcare System, 19 SW 3d 678 (Mo 2000). 9. Cheshire v Southampton Hospital Association, 53 Misc 2d 355, 278 NYS 2d 531 (1967).
5. Dubin v Michael Reese Hospital and Medical Center, 83 Ill 2d 277, 415 NE 2d 350 (1980).
10. Butler v Northwestern Hospital of Minneapolis, 202 Minn 282, 278 NW 37 (1938).
6. Kirsch v Picker International, Inc., 753 F 2d 670 (8th Cir 1985).
11. Trieschman v Eaton, 224 Md 111, 166 A 2d 892 (1961).
Peter B. Mancino, Esq, and Peter G. Siachos, Esq, are from Garfunkel, Wild & Travis, PC, Great Neck, New York. Peter B. Mancino, Esq, Garfunkel, Wild & Travis, PC, 111 Great Neck Road, Great Neck, NY 11021; e-mail:
[email protected]. Peter G. Siachos, Esq, Garfunkel, Wild & Travis, PC, 411 Hackensack Ave, Hackensack, NJ 07601; e-mail:
[email protected].